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NCT00609739 · ClinicalTrials.gov registry record · Phase 1

Cytosine Arabinoside and Mitoxantrone for Patients With Juvenile Myelomonocytic Leukemia Receiving Repeat Stem Cell Transplantation

A Phase 1 study, sponsored by Masonic Cancer Center, University of Minnesota.

Terminated
Registry status
Phase 1
Development phase
1
Enrollment target

NCT00609739: Clinical Trial Phase 1 study, sponsored by Masonic Cancer Center, University of Minnesota.

NCT00609739 is a Phase 1 study that was terminated before completion, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00609739, a Phase 1 study, was terminated before completion, sponsored by Masonic Cancer Center, University of Minnesota.

TERMINATED
Registry status
Phase 1
Development phase
1 participants
Enrollment target

Study Summary

RATIONALE: Giving chemotherapy drugs, such as cytarabine and mitoxantrone, before a donor stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When certain stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine, methotrexate, and methylprednisolone before or after transplant may stop this from happening. PURPOSE: This phase I/II trial is studying the side effects and best way to give high-dose cytarabine together with mitoxantrone in treating patients with juvenile myelomonocytic leukemia undergoing a second donor stem cell transplant.

Primary Outcome

Number of patients who were free of disease and alive at 1 year.

Interventions

  • DRUG methylprednisolone
  • DRUG filgrastim
  • DRUG methotrexate
  • DRUG cytarabine
  • DRUG cyclosporine

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 1999-06
Est. Completion 2010-06
Phase Phase 1

Why NCT00609739 stopped before completion

NCT00609739 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 5 interventions - of which methylprednisolone is the first listed.

NCT00609739 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00609739 about?

NCT00609739 is a clinical study titled "Cytosine Arabinoside and Mitoxantrone for Patients With Juvenile Myelomonocytic Leukemia Receiving Repeat Stem Cell Transplantation". RATIONALE: Giving chemotherapy drugs, such as cytarabine and mitoxantrone, before a donor stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When certain stem cells from a donor are infused into the patient the...

What is the current status of trial NCT00609739?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 1999-06. Estimated completion is 2010-06.

What interventions are being tested in trial NCT00609739?

The interventions under investigation include: methylprednisolone (DRUG), filgrastim (DRUG), methotrexate (DRUG), cytarabine (DRUG), cyclosporine (DRUG).

Who is sponsoring clinical trial NCT00609739?

This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00609739's enrollment target sits among peer trials

1 2001st of 2000 the lowest of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00609739, the US trial registry maintained by the National Library of Medicine. NCT00609739 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.